SPIWay Endonasal Access Guide— 510(k) K153686

Substantially Equivalent

Spiway, LLC

FDA 510(k) clearance K153686 for SPIWay Endonasal Access Guide, Substantially Equivalent on 2016-01-28. Applicant: Spiway, LLC. Device class: 1.

Clearance details

Applicant: Spiway, LLC
Product code: Code LYA
Device class: Class 1
Regulation: 21 CFR 874.4780
Advisory panel: Ear, Nose, Throat
Date received: 2015-12-23
Decision date: 2016-01-28
Decision: Substantially Equivalent
Clearance type: Special
Location: San Clemente, CA, US

Download summary PDF View on FDA.gov ↗

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K181696 — ChitoZolve2018-11-30

More clearances from Spiway, LLC

K180141 — SPIWay Endonasal Access Guide2018-02-16
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Data sourced from openFDA. This site is unofficial and independent of the FDA.